Wear-Time Trial for Self-Fitting Hearing Aid

NCT04823494 | Completed Results FDA Device

• 1 other identifier: X-Men
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This document describes a clinical validation study for a double-blind repeated-measures comparative study of the Great Nordic (GN) self-fitting method to a validated audiology-best-practices method when fitting the GN Self-fitting Hearing Aid, a device intended for persons aged 18-75 years old who have mild-to-moderate hearing loss. A crossover wear-time field trial will be conducted. The focus of the study is on the validity of the self-fitting process used to select appropriate frequency-gain characteristics for the GN Self-fitting Hearing Aid, and the safety and effectiveness of the device.

Conditions

Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (1)

• Aided Abbreviated Profile of Hearing Aid Benefit (APHAB)

  The APHAB is a 24-item self-assessment of the amount of trouble the respondent has with communication in everyday situations. Sample question: "When I'm at the dinner table with several people, and I am trying to have a conversation with one person, understanding speech is difficult." For each of the 24 items, person asked to select one of the following percentages to indicate how frequently this occurs: Always (99%); Almost Always (87%); Generally (75%); Half-the-time (50%); Occasionally (25%); Seldom (12%); or Never (1%). Mean scale scores are expressed as a percentage or proportion representing the average frequency of difficulty experienced. An APHAB global score based on the 18 items from the three speech-communication subscales was used in the statistical analyses. APHAB scores were obtained unaided (Visit 1) and following use of the hearing aids for 10-14 days for each fit (Visits 2 \& 3; aided). The primary outcome is the mean difference in aided scores, Self-Fit minus Pro-Fit.

  10-14 days

Secondary Outcomes (1)

• Quick Speech in Noise Test (QuickSIN)

  Measurement after 10-14-day wear time for each fit.

Study Arms (2)

Pro-Fit followed by Self Fit

EXPERIMENTAL

Hearing aids fit by a professional hearing care provider using best practices followed by patient ...

Device: Hearing aids

Self-Fit followed by ProFit

EXPERIMENTAL

Hearing aids fit by patient followed by ...

Device: Hearing aids

Interventions

Hearing aids DEVICE

Earbud style hearing aids fit to both ears

Pro-Fit followed by Self Fit; Self-Fit followed by ProFit

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild-to-moderate bilateral sensorineural hearing loss (thresholds from 250 - 8000 Hz less than 60 decibels Hearing Level (dB HL) and from 2000 - 8000 Hz, at least one threshold greater than 20 dB HL)
• Mix of male and female subjects (aiming for a representative balance)
• Mix of prior hearing-aid use (aiming for 70-80% persons with no prior hearing aid use)
• years old (aiming for primarily 50-70 years old, with avg. age \~65 years)
• Apple iPhone (iOS 14 compatible or greater, as required for the SELF-FIT app)
• Able to read and comprehend English
• Patient willing to provide informed consent

You may not qualify if:

• Hearing outside of limits noted above
• Self-reported ear-related pathology (including chronic severe dizziness or chronic severe tinnitus)

Sponsors & Collaborators

• GN Hearing A/S: lead
• Northwestern University: collaborator
• Sertoma Speech and Hearing Center: collaborator
• Vanderbilt University: collaborator

Study Sites (2)

Sertoma Speech and Hearing Center

Palos Hills, Illinois, 60465, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

Related Publications (2)

• Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005.

  PMID: 7789669 BACKGROUND

• Killion MC, Niquette PA, Gudmundsen GI, Revit LJ, Banerjee S. Development of a quick speech-in-noise test for measuring signal-to-noise ratio loss in normal-hearing and hearing-impaired listeners. J Acoust Soc Am. 2004 Oct;116(4 Pt 1):2395-405. doi: 10.1121/1.1784440.

  PMID: 15532670 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Limitations and Caveats

The minimum N needed to achieve the desired statistical power was 32 and 40 participants were enrolled to allow for attrition. In the end, only 3 participants were exited from the study or withdrew, leaving 37 with complete data. Of the 3 with incomplete data, 2 resulted from technical issues with the devices or app. However, both per-protocol analyses (summarized above) and intention-to-treat analyses yielded the same findings, indicating that the few missing data were inconsequential.

Results Point of Contact

• Title: Todd Fortune
• Organization: GN

tfortune@gnresound.com

763-772-5566

Study Officials

• Todd Ricketts, Ph.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Sumitrajit Dhar, Ph.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: June 18, 2021
• Primary Completion: September 30, 2021
• Study Completion: December 20, 2021
• Last Updated: May 11, 2022
• Results First Posted: May 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)